NDC directory

Pantoprazole Sodium

pantoprazole sodium · Avenacy, LLC · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

83634-751ANDAProton Pump Inhibitor [EPC]
Open FDA's page for this record
Product NDC
83634-751
Generic name
pantoprazole sodium
Labeler name
Avenacy, LLC
Brand name
Pantoprazole Sodium
Finished
true
Listing expiration date
20271231
Marketing category
ANDA
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SPL ID
1211fb5b-522a-4df5-8f70-bf6156984f8e
Product type
HUMAN PRESCRIPTION DRUG
Marketing start date
20260930
Product ID
83634-751_1211fb5b-522a-4df5-8f70-bf6156984f8e
Application number
ANDA219973
Brand name base
Pantoprazole Sodium
Active ingredients
  1. Name
    PANTOPRAZOLE SODIUM
    Strength
    40 mg/10mL
Packaging
  1. Package NDC
    83634-751-10
    Description
    10 VIAL, SINGLE-DOSE in 1 CARTON (83634-751-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-751-41)
    Marketing start date
    20260930
    Sample
    false
Route
INTRAVENOUS
Pharm class
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
Harmonized identifiers (openFDA)
Manufacturer name
Avenacy, LLC
RxCUI
283669
SPL set ID
70378eba-3904-4491-9f6d-00f5d1501c4a
Is original packager
true
UNII
6871619Q5X
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.